A Phase 1 Study of Chronically-Dosed, Single-Agent ABT-888 in Patients With Either BRCA 1/2 -Mutated Cancer; Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer; or Basal-Like Breast Cancer

Inclusion Criteria:

- Histologically or cytologically confirmed malignant solid tumor meeting ≥ 1 of the
following criteria:

- Documented BRCA1/2 mutation AND a BRCA-related malignancy (e.g., primarily
breast or ovarian cancer, but may include prostate or pancreatic cancer)

- Platinum-refractory ovarian, fallopian tube, or primary peritoneal cancer

- Platinum-refractory is defined as progression or recurrence within 6 months
of initial platinum response

- No platinum-resistant disease, defined as no prior response to
platinum-based therapy (i.e., evidence of progression within 2-3 courses of
beginning initial platinum-based therapy)

- Patients with platinum-sensitive disease must have known BRCA mutations

- Basal-like breast cancer, defined as estrogen and progesterone
receptor-negative, HER2-negative, and/or expression profile of EGFR and
cytokeratins 5/6 consistent with basal phenotype

- "Triple-negative" phenotype (i.e., negative hormone and HER2 receptors)
allowed

- Patients with known "triple-negative" phenotype but unknown basal
phenotype will have their tumor blocks assessed for basal markers

- Progressive disease after standard therapy OR no acceptable standard treatment
options available

- Patients without a known BRCA mutation must have archived tumor tissue samples
available for assessment of BRCA1/2 protein expression by immunohistochemistry

- Patients without a known, documented BRCA mutation from Myriad Genetic
Laboratories must have a probability of harboring a BRCA gene mutation as
assessed by BRCAPRO computer program

- Patients with a probability of harboring a BRCA gene mutation of ≥ 20% must
undergo formal BRCA testing by Myriad Genetic Laboratories

- Patients with a diagnosis of a BRCA mutation based on a non-Myriad test
must undergo Myriad BRCA gene sequencing

- Known deleterious BRCA1 or 2 mutation or a mutation of uncertain significance
allowed

- Patients enrolled on dose levels VI-IX must be willing to undergo skin biopsies and
hair sample collection before starting treatment and on day 4

- Patients who are receiving therapeutic doses of anticoagulation are exempt

- Patients with BRCA mutations who are enrolled in the 6-patient expansion group at the
MTD (or dose level IX) must agree to tumor biopsies

- Tumors must be easily accessible for biopsies with low likelihood of
complication

- Patients should not be on therapeutic doses of anticoagulation

- Patients with BRCA mutations who are enrolled in the 6-12 patient expansion group at
the MTD (or dose level IX) must agree to tumor biopsies; therefore patients enrolled
in this cohort should have tumors easily accessible for biopsies with low likelihood
of complication and these patients should not be on therapeutic doses of
anticoagulation

- Hormone receptor status not specified

- Menopausal status not specified

- ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)

- Life expectancy > 3 months

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin ≤ 2.0 mg/dL

- Transaminases ≤ 2.5 times upper limit of normal

- Creatinine normal OR creatinine clearance > 50 mL/min

- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV infection allowed provided CD4 count > 500/mm³

- Able to swallow pills

- No concurrent uncontrolled illness including, but not limited to, any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situation that would limit compliance with study
requirements

- No concurrent protease inhibitors for patients with HIV infection

- Recovered from all prior therapy

- More than 4 weeks since prior major surgery, radiotherapy, or chemotherapy (6 weeks
for nitrosoureas or mitomycin C)

- At least 4 weeks since prior flutamide (6 weeks for bicalutamide) for prostate cancer

- Concurrent ongoing luteinizing hormone-releasing hormone agonist therapy for
prostate cancer required

- Concurrent IV bisphosphonates for bone metastases or hypercalcemia allowed provided
treatment was initiated prior to study entry

- No concurrent chemotherapy

- No other concurrent investigational agents

- No other concurrent anticancer therapy

- Patients with CNS metastases must be stable after therapy for CNS metastases (such as
surgery, radiotherapy or stereotactic radiosurgery) for > 3 months and must be off
steroid treatment prior to study enrollment and must have a life expectancy secondary
to that of 3 months or greater to be eligible

- Active seizure or history of seizure disorder are excluded